Key aspects of the MedCanG: New perspectives for holders of narcotics licenses!

When the Medical Cannabis Act (MedCanG) came into force on April 1, 2024, a new chapter in the medical and scientific use of cannabis began in Germany. The law creates a legal framework and at the same time offers considerable opportunities for companies in the cannabis sector. Holders of existing licenses under Section 3 of the Narcotics Act (BtMG) are now faced with the exciting task of exploiting the opportunities for the legal cultivation, production and distribution of medicinal cannabis. In particular, this requires them to adapt or transfer their valid license under Section 3 BtMG to the detailed requirements of Section 4 MedCanG. In the following sections, you will find out which specific steps are required for this, which pitfalls need to be avoided and how the experts at TentaConsult Pharma and Med can support you in this task.

From pain relief to the treatment of inflammatory diseases and epileptic seizures, cannabis has proven to be a versatile remedy for thousands of years. Despite its historical use, international bans and restrictive regulatory measures in the 20th century led to a significant regression in the research and use of cannabinoids in medicine. A turning point was the discovery of the endocannabinoid system in 1992, which, together with a gradual destigmatization of cannabis, initiated a reassessment of its medical potential.

The entry into force of the MedCanG on April 1, 2024 marks the beginning of a new era in the use of cannabis for medical and scientific purposes. The law legalizes and regulates the cultivation, production, trade, distribution and use of cannabis and its derivatives.

New opportunities for holders of licenses under Section 3 BtMG thanks to the Medical Cannabis Act!

Holders of a license in accordance with Section 3 BtMG are facing significant new opportunities with the MedCanG. The law enables them not only to establish themselves and expand in a dynamically growing market, but also to

• Advance the research and development of novel cannabis-based medicines and therapies.
• To develop innovative dosage forms that enable more precise dosing.
• To use cannabis for research in previously unexplored medical areas.
• To significantly expand the therapeutic scope of cannabis.

However, in order to fully exploit these opportunities, a careful adaptation and transfer of the existing licenses to the detailed requirements of Section 4 MedCanG is necessary.

Relevant steps for successful adaptation to the Medical Cannabis Act!

The adaptation process begins with the submission of a formal application to the competent authority, the Federal Institute for Drugs and Medical Devices, more precisely to the Federal Opium Agency. This application must be comprehensive and contain the following information, as stipulated in § 7 MedCanG:

• Full names, first names and addresses of the applicant and all responsible persons, as well as the company, if applicable.
• A current certificate of good conduct for the applicant and each responsible person.
• Evidence of the required expertise of each responsible person and declarations as to whether they can fulfill their duties on an ongoing basis.
• Detailed description of the premises location including all relevant geographical details.
• Specific information on the handling of cannabis, distinguishing between medical and scientific purposes, as well as the type of cannabis used.
• For research projects, a detailed explanation of the scientific project based on relevant scientific literature is also required.

For full-range wholesalers, the permit for individual varieties may be waived under certain conditions.

With TentaConsult Pharma and Med safely through the adaptation process to the MedCanG!

The entry into force of the Medical Cannabis Act represents a significant milestone for the medical cannabis sector in Germany. In order to be successful in this rapidly developing market, it is crucial to adapt licenses to the new legal requirements. This adaptation requires not only careful planning and detailed application processes, but also compliance with specific quality and safety standards.

TentaConsult Pharma and Med has the expertise and experience your company needs to overcome these challenges and take full advantage of the MedCanG. With our support, you can ensure that your company takes the necessary steps to become a leader in the medical cannabis market.

Contact us to learn how we can support you through this transition and take the first step towards a successful future in the medical cannabis space.